BIO-LOGIC SLEEPSCAN NETLINK

Standard Polysomnograph With Electroencephalograph

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Bio-logic Sleepscan Netlink.

Pre-market Notification Details

Device IDK003681
510k NumberK003681
Device Name:BIO-LOGIC SLEEPSCAN NETLINK
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactNorman E Brunner
CorrespondentNorman E Brunner
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeOLV  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-30
Decision Date2000-12-21

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